Health Policy

FDA Inaction on Antibiotics Is Making the World Deadlier

Turkeys raised without the use of antibiotics at a farm in Lebanon, Pennsylvania

This month, the U.S. Food and Drug Administration issued a guidance document (PDF) on the use of antibiotics in farm animals, which accounts for four-fifths of all antibiotics administered in the U.S. The document notes excessive use leads to the spread of antibiotic-resistant diseases in both animals and humans. Meanwhile, the vast majority of agricultural antibiotics aren’t used for high-impact purposes—to treat sick animals—but to promote growth and as a cheap way to prevent infection. The FDA suggests pharmaceutical companies voluntarily change a few labeling and marketing practices to help address that problem.

The FDA’s response to the growing threat of antibiotic resistance is so inadequate that it makes sister agencies dealing with climate, financial instability, and trade challenges look all-powerful. The FDA’s inability to tackle the profligate and destructive use of a vital medical technology reflects a larger failure of international leadership to preserve the life-saving potential of antibiotics for the next generation.

Bacteria remain significant causes of illness and death: In 2011, the Centers for Disease Control and Prevention reported nearly 19,000 cases of pertussis and 17,000 cases of streptococcal pneumonia in the U.S. But antibiotics have transformed the battle against bacteria and saved millions of lives since penicillin was first used to treat infected wounds in World War II.

The threat of antibiotic resistance extends beyond the U.S. This is a global health emergency. Because of the emergence of antibiotic-resistant bacteria, common antibiotics are increasingly ineffective against them. Today, the original wonder-drug penicillin only treats from one-quarter to two-thirds of strains of pneumonia present worldwide. And the CDC suggests that 15 infections, including MRSA and some strains of tuberculosis, are resistant to multiple antibiotics.

This spreading resistance among old antibiotics has occurred alongside a thinning pipeline of new ones. The number of antibacterial drug application approvals has dropped (PDF) from 19 in 1980-84 to two in 2005-09. Compounding the problem, the time gap between antibiotic introduction and the emergence of resistant infections appears to be shrinking. It took 22 years between penicillin’s widespread use and the emergence of penicillin-resistant pneumococcus. It took nine years between the introduction of the antibiotic tetracycline and the identification of tetracycline-resistant shigella. It took just one year (PDF) between the introduction of ceftaroline and the identification of ceftaroline-resistant staphylococcus.

Three major factors unnecessarily increase the risk of antibiotic-resistant bacteria strains evolving: overuse of antibiotics where they have low or no impact, failure to complete antibiotic treatment courses, and low-quality drugs. The first of those problems is prevalent in the U.S. and even more so worldwide. Every time an antibiotic is administered, the bacteria present in the body is given a chance to evolve into an immune form. And yet the CDC estimate that up to 50 percent of all the antibiotics prescribed for human use in the U.S. are not needed or are not optimally effective. For example, only 10 percent of acute-bronchitis cases are caused by bacteria, but doctors prescribe antibiotics to treat the condition 70 percent of the time.

Then there is the use of 30 million pounds of antibiotics a year in agriculture to marginal benefit in terms of growth promotion and disease prevention. Denmark recently banned all use of antibiotics in animal feed or water for these purposes, and overall agricultural antibiotic use halved. Despite that, Danish farmers still appear able to bring home the bacon—total pig production is a little higher than it was 10 years ago.

Denmark, however, is the exception and the U.S. is more the rule when it comes to the use of antibiotics for agricultural purposes. In China, according to Bloomberg Businessweek’s Christina Larson, the average person consumes 10 times the volume of antibiotics as they do in the U.S.—although prescription rates in hospitals have declined 15 percent over the past two years. China also uses four times more antibiotics on animals than the U.S. And worldwide, around half of all antibiotics for human use are purchased from private vendors without a prescription—in part because of excess faith in them as drugs that can cure almost any condition.

Dealing with the growing threat of resistance thus requires a global solution. Wherever bacterial diseases originate, they rapidly spread worldwide. Cholera may have originated in Asia, and syphilis (possibly) in the Americas, but both infect people everywhere. And the same applies to resistant strains of bacteria. The more we misuse an antibiotic today, the higher the risk it will be useless when we need it tomorrow.

That’s why the FDA’s response on antibiotics has been doubly impotent–pathetically weak on the domestic problem and silent on global coordination. The agency’s latest guidance document politely requests in an absolutely nonbinding manner that pharmaceutical companies change their drug labeling to suggest antibiotics shouldn’t be used to promote growth in farm animals. It also suggests but fails to demand that antibiotics designed to be regularly added to water and feed stocks for entire herds, coups, or sheds of animals should be marketed as products that require a vet to administer.

Rather than issuing nonbinding statements, the FDA should be working with foreign governments, the United Nations Food and Agriculture Organization, and the World Health Organization to craft a binding global agreement on the use of antibiotics—one that will cover research, prescription regimes, and use in agriculture. If we don’t want to return to the days when even a minor injury risked a death sentence from infection, now is the time to act.